DSHEA Tutorial: Images or Symbols as Disease Claims

Claims

Non-Compliant Workaround #7: implying a disease claim with pictures, graphs, symbols or other means.

Summary: disease claims don’t have to be stated verbally. They can easily be made with images. An image making a disease claim is as non-compliant as the equivalent words.

Here’s the text from the FDA’s guidelines:

[A dietary supplement is out of compliance if it] (4) has an effect on disease through one or more of the following factors:

(e) use of pictures, vignettes, symbols, or other means;

The FDA used the EKG tracing as an example of a symbol that is making a disease claim. They believe that a picture of a heart such as you’d find on a valentine is not going to be a problem, however an EKG tracing would suggest a pathology of the heart, and so it should be avoided. That would also include X-rays of broken bones or any other recognizable symbol or image to describe a disease state.

This is a huge gray zone here and it brings up something that I myself can’t yet answer and that is, is there somebody at the FDA who can actually help you approve your artwork before you spend the time and money in putting it on your website and product labels. Here’s a page where I located a few people, one of whom actually returned my phone call and was able to answer some questions regarding DSHEA compliance: Division of Dietary Supplement Programs.

Next: disease claims by virtue of the product doing what drug classes do.

Last modified: August 9, 2009  Tags: ,  В·  Posted in: Claims